FDA Inspection
Custompax, Inc., dba VitaganicCustompax, Inc., dba Vitaganic – FDA Inspection, Oct 3, 2011
Record Details
This FDA Inspection record concerns Custompax, Inc., dba Vitaganic, with an inspection on October 3, 2011, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Inspection Date
- October 3, 2011
- Product Type
- Food/cosmetics
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ID · 4cf2bc37-3d1b-475b-9817-7bf8e51005f8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 748186
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
9- 21 CFR 111.73Specifications met - identity, purity, strength, composition
- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.35(b)(1)(ii)Procedures - equipment; calibrating, inspecting, checking
- 21 CFR 111.260(j)(2)(iv)Batch record - initials; verifying component
- 21 CFR 111.260(j)(2)(ii)Batch record - initials; verifying weight
- 21 CFR 111.260(d)Batch record - component; unique identifier
- 21 CFR 111.120(b)Quality control operations - specifications; components, packaging, labels
- 21 CFR 111.117(d)Quality control operations - equipment functions
- 21 CFR 111.105(d)Quality control - basis; tests, examinations
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Other FDA inspections of Custompax, Inc., dba Vitaganic
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 27, 2016 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| August 28, 2015 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 25, 2014 | OAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| November 6, 2012 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| June 9, 2010 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
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